# FDA 483 - Tec Com Gmbh - August 23, 2018

Source: https://www.keypedia.com/records/483/tec-com-gmbh/08c32b7b-75a3-4154-88d9-458e34003ac0

> FDA 483 for Tec Com Gmbh on August 23, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tec Com Gmbh
- Inspection Date: 2018-08-23
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Tec Com Gmbh, a medical device manufacturer, was cited for two significant observations during an FDA inspection. The firm failed to report a recall of temperature-regulating medical devices with faulty heating elements to the FDA, despite five devices being in the US market. Additionally, their sampling plans for incoming inspection of critical outsourced components lacked valid statistical rationale, indicating deficiencies in their quality system and regulatory compliance.

## Related Officers

- [Project Director](https://www.keypedia.com/people/eric-m-padgett/a42150bc-aa7f-4076-8a68-af47ff465bac)

Company: https://www.keypedia.com/companies/tec-com-gmbh/9e114a0e-4937-498f-9295-e1f3274e8ba8

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd